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Govt may bring regulatory law on medical devices: Minister

Addressing a conference on medical technology, Chemicals and Fertilisers Minister Ananth Kumar also assured the industry that he would take up the issue of ban on imports of refurbished medical devices with the ministries of finance, environment and health.

“There is a proposal from the industry to come out with the Medical Devices and Technology (Promotion and Regulation) Act. I will hold discussion with Health Minister,” he said at the conference.
With inputs from the industry, the bill can be introduced in Parliament as early as the Winter Session, he said.

Stating that medical devices is a sunrise industry, the minister said the government intends to promote this important sector and “whatever legislative framework that is required on this issue can be considered”.

India can develop as a medical devices hub globally and become an example of ‘Make in India’ campaign. India is already offering software solutions for manufacturing of medical devices globally and the country has the potential to become a full-range solutions provided if it starts manufacturing hardware as well, he added.

On the ban of imported refurbished medical devices, Kumar said their utility in second tier and third tier medical facilities is an important issue and he would lead a delegation of the industry to discuss the matter with the finance minister in the next 15 days in order “bring the matter to a logical conclusion”.

On demands for higher duties on import finished equipments to boost domestic production, Kumar said: “Already there has been gradual increase in the last two years. It is to the tune of 11-12 per cent. “Import duties on raw material have been reduced. Whatever tariff incentives are required; there will be a meeting of myself with Health Minister and Finance Minister,” he said.

Kumar said that industry should suggest a “considered” tariff structure on imported medical devices and “I am ready to take up the issue with the Finance Minister”.

Stating that affordability for poor patients of the country is a prime concern, he said the government will take steps to promote manufacturing of these devices in India so that the cost can be brought down.

On taxation on medical devices, Kumar said that the government is taking several steps to promote the medical devices sector in the country. “The inverted duty structure has been set right. The GST will further bring down the taxation in the sector by almost 12 per cent.”

Kumar further said, “The first Medical Technology Park has already been set up in Vishakhapatnam, Andhra Pradesh with an investment of Rs 1,200 crore. 

Himachal Pradesh, Gujarat, Telangana and Maharashtra have also shown interest in setting up such parks and the Centre is ready to support these efforts. 

Setting up of these parks can bring down the manufacturing cost by another 30 per cent and make Indian Medical technology sector globally competitive, due to pooling of common facilities.”

Kumar asked the medical devices industry to not treat it as a business but consider it as “providing holistic healthcare to 1.25 billion people”. He expressed concern over the low usage of drugs in the population below poverty line.

The minister also called upon the medical devices manufacturers to undertake research and innovation, and not confine themselves to reverse engineering or re-engineering. He stressed on customised medical devices for Indian conditions and requirements.

“Industry should strive to be a source for not only Indian requirements but also cater to rest of Asia and Africa. The industry’s demand of legislation for medical technology is a good idea but it requires brainstorming. A task force would be set up to discuss various issues with different industry associations,” he said.

Kumar also reiterated the demand for a separate ministry for pharmaceuticals and medical devices. CII Medical Technology Division Chairman Himanshu Baid demanded that ban on refurbished equipments should be removed to bring down the healthcare cost in tier II and III cities. “The manufacturers are giving extended warranty. So there should not be any ban,” Baid, who is MD of Polymedicure Ltd, added. 
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